510(k) · Cleared
ClearedStarkey TM-3, TM-5 High Frequency Tinnitus Masker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starkey Laboratories, Inc. · KLW Masker, Tinnitus
Cleared on Dec 6, 1996 as substantially equivalent to K940667 (Starkey Laboratories, Inc., 1994) after a 45-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.
- Decided
- Dec 6, 1996
- Review
- 45 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940667 (1994). 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK940667 Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc. · 1994
- This deviceK964216 Starkey TM-3, TM-5 High Frequency Tinnitus MaskerStarkey Laboratories, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK982451 Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK021202 UltraquietSound Technique System, LLC · 2002
- Descendant · 2 generations on · 0 of its ownK132965 Solace Sound GeneratorsAmplisound Hearing Products & Services · 2014
- Descendant · cites it directly · 0 of its ownK070648 The Inhibitor, Model 001Melmedtronics, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK031624 Tinnitus RXTinnitus Control, Inc. · 2003
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K982451Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999 · cites it directly2descendants
- K021202UltraquietSound Technique System, LLC · 2002 · cites it directly1descendant
- K132965Solace Sound GeneratorsAmplisound Hearing Products & Services · 2014 · 2 generations on0descendants
- K070648The Inhibitor, Model 001Melmedtronics, Inc. · 2007 · cites it directly0descendants
- K031624Tinnitus RXTinnitus Control, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940667 | Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid | Starkey Laboratories, Inc. | 1994 | — |
| 0 (this device) | K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus Masker | Starkey Laboratories, Inc. | 1996 | — |
| +1 | K982451 | Ttcghi-T and TTCTN3-T-T | Tinnitus Treatment Centers, Inc. | 1999 | — |
| +1 | K021202 | Ultraquiet | Sound Technique System, LLC | 2002 | — |
| +2 | K132965 | Solace Sound Generators | Amplisound Hearing Products & Services | 2014 | — |
| +1 | K070648 | The Inhibitor, Model 001 | Melmedtronics, Inc. | 2007 | — |
| +2 | K031624 | Tinnitus RX | Tinnitus Control, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLW device
- #1 K260413 Levo Gen 2 Tinnitus Therapy Systemscore 11.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940667 | Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidSummary page 1…ofessional in a completed form, not being intended for final assembly. The Starkey TMs are substantially equivalent to the masking portion of the Starkey CE- 8 TML/TMC (K940667). The Starkey TMs are BTE Tinnitus Maskers with a white noise generating circuit which can be tuned to match the frequency and in… | 1994 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KLW
261in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLW
No recall names KLW since 2007.
Adverse event reports per year · KLW
4in 2015
MAUDE reports naming product code KLW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 4 | 58 | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 150 | 0 | 0 |
| 2014 | 4 | 164 | 0 | 0 |
| 2015 | 4 | 107 | 0 | 4 |
| 2016 | 3 | 114 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | 261 | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964216: Starkey TM-3, TM-5 High Frequency Tinnitus Masker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964216
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026